09 February 2008

The current buzz among diabetic experts this week is the puzzling results observed from the ACCORD Trial, or more lengthily known as the Action to Control Cardiovascular Risk in Diabetes. I even got an email from my good friend, Jay, who was equally surprised, and is very concerned why diabetics who are trying to lower their blood sugar will suddenly die.

Jay, along with other health-conscious diabetics around the world, has every reason to be alarmed. The conventional wisdom in diabetes management is that the lower the blood sugar, the better it is. Why then, did 257 people enrolled in the study die unexpectedly, when they were under a strict and very intensive treatment program to lower their blood sugar?

Before answering that question, let's have a brief background about theACCORD Trial....

It is a large clinical study involving 10,251 adults (average age of 62) from the US and Canada, with established type 2 diabetes who are at especially high risk of cardiovascular disease (CVD).

WHY does the study seek to test the 3 treatment approaches? Because previous clinical studies have shown that both blood sugar lowering and blood pressure lowering reduce diabetic complications involving the eye, kidney, and nerves, and statin treatment lowers CVD events like stroke and heart attacks, researchers would like to know if aggressive treatment modalities can lengthen and improve the lives of affected patients.

Differentiating between aggressive and standard treatment targets: In the ACCORD Trial, the standard treatment group were treated to a target A1C level of 7 to 7.9percent, while for those in the aggressive blood sugar treatment group, the target is to achieve an A1C of less than 6 percent, a level of blood sugar that is similar to that of a person without diabetes.

What was so alarming about current results? After almost four years of treatment, 257 participants in the aggressive treatment group died, compared with 203 within the standard-treatment group.

Should Jay and other diabetics be alarmed with these findings? Nothing can be more frustrating than having all your "sacrifices" (read as boring and tasteless diets, exercising regularly, and religiously taking your prescribed medicine). My friend Jay is one of those obedient patients. Telling him that everything he does to remain healthy is useless will surely disappoint him, and may send him backsliding to his old unhealthy lifestyle before.

The answer is NO. There is no need to be alarmed.

Reasons why Jay should not worry about the ACCORD Trial results:

The deaths that occurred were under an experimental diabetic treatment approach --- lowering blood sugar to an A1C of less than 6 percent --- which is very aggressive in my opinion. I am sure Jay's doctor is only using the standard regimen on him. The aggressive treatment might have taxed the trial's subjects too much. Imagine taking four shots of insulin and three pills and checking their blood-sugar levels four times a day! Too much stress kills, remember? How much more in patients who were very vulnerable?

The yearly death rates for both standard and aggressive treatment groups are 1.4 percent and 1.1 percent respectively, which are still way, way below the 5 percent typical of other diabetic patients at similarly high risk. This means that generally speaking, the diabetic treatment protocols still are better than not getting any treatment at all.

The mean age of the participants is 62, and are not only type 2 diabetics but are also selected to be included in the study because of their "especially high risk of cardiovascular disease (CVD)." Jay is 40, has controlled blood sugar, controlled blood pressure, has stopped smoking, and is not obese. He exercises regularly and even ran his first marathon weeks ago.

In my practice, my treatment strategy had always been conservative. I resort to aggressive strategies only when there's an emergent need for it. I have always believed that the human body is not used to abrupt rollercoaster-ups-and-downs. During disease states, its ability to adapt becomes even more compromised. Going slow might be the more prudent approach. Instant and abrupt cures might cause more harm than benefit, as we have seen from the latest ACCORD Trial results.

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UPDATE: The ADVANCE Trial, a similar prospective study like ACCORD conducted on more than 11,000 patients from Canada, Europe, Australia, and Asia (including the Philippines), did NOT find a similar increase in deaths among patients receiving the most intense therapy for 5 years (average).

thank you very much for the very informative post. i did learn a lot from it as i always do learn a lot from you.

my doctor has actually required me to have an A1C level of below 6.0 and has been monitoring this like a hawk ever since i started seeing her two years ago.

i have met it most of the time with a few relapses (over 6 A1C) once a year.

personally, i am not worried about myself because i am not taking any medication. my main diabetes "medicine" is exercise and diet and so far it has worked.

my blood sugar level is around 120 everytime i measure myself in the morning. i know it's over normal but i am not overly concerned about it. perhaps that's why i am still alive - the study suggests that the stress of trying to stay normal is one of the reasons why people die.

i am concerned about jet though because she does take a lot of meds for her diabetes. i'll make her read your post. she has an appoinment with her doctor next week and i want her to talk about this with him.

While I am not a diabetic, I am aware that I am a pre-diabetic, having both parents who have the condition.

I have avoided taking canned drinks for years now and I try to limit my intake of carbs. But there were occasions when I felt an onset of cold sweat, probably indicating a condition of insufficient blood sugar. Whenever I feel this, I try to take a beverage drink or eat something.

Is this an indication of sugar level fluctuations that can lead to diabetes?

BATJAY - For me, an A1C of between 6 and 6.5 is still ideal. I don't really require my diabetic patients to go lower than this range. Regarding Jet, I am worried about her , too. Her nightly duties can be stressful. I know it is difficult, but I think she should consider making time for some form of regular exercise. I agree with your opinion that in some patients, exercise can replace taking medicines. I have one patient myself who is like that. So far, his blood sugar levels are well-controlled. Thank you for your email again and please take good care of Jet.

BAYI - Hello! How are you doing?Regarding your question --- blood sugar levels always fluctuate, even in a normal person. The problem arises when the body isn't able to cope with these changes. As long as the body can handle it, there is no problem. The answer to your question is...not necessarily. To be on the safe side, we do our best not to miss out on any major meals , eat 6 small meals daily and exercise regularly.

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DISCLAIMER

Information found here is the author's opinion and should not be used as replacement for the medical advice of your personal physician. If you feel sick and you feel it is an emergency, consult your physician or the nearest hospital immediately. Your physician is STILL the best person who can manage you medically.